Gxp Systems Specialist - Ocugen : Job Details

Job Purpose

As part of the Ocugen team, the GxP Systems Specialist will implement and manage the Ocugen Veeva vault and other GxP applications to meet regulatory requirements and business needs.

The ideal candidate should bring experience working in enterprise application environments in life sciences with the ability to manage multiple projects across different functions. The candidate should also be experienced as a technical lead for IT (Information Technology) projects.

This position is located in Malvern, PA, USA.

Duties and responsibilities

Accountable for implementation/delivery of Veeva and GxP applications to meet Ocugen business needs with a focus on regulated functions:

• Help define project scope and deliverables to support business goals in collaboration with senior management stakeholder

• Participate in the development of solutions and manage project/change timelines.

• Evaluate Veeva general releases, conduct assessments/POCs, and develop business cases for implementing new enhancements or configurations to align with enterprise needs.

• Proficient in business and system administration with extensive hands-on experience configuring Veeva Vault platforms, including Quality, QMS, Training, Clinical, and RIM applications.

• Liaise with computer system vendors, Quality, and the business to coordinate implementation activities.

• Work with the business to develop system and user requirements.

• Define and oversee documentation of configuration and design specifications.

• Participate in the authoring and execution of implementation plans/qualification tests.

• Participate in the authoring of computerized system validation documentation.

• Author Ocugen CSV (Computer System Validation) standards, procedures, and work instructions.

Management Of GxP Systems Lifecycle

• Management of system access and permissions.

• Perform change management activities.

• Design solutions and manage configuration.

• Liaise with users to resolve issues.

• Create reports based on defined requirements.

• Maintain system documentation.

• Build systems reports and dashboards.

• Propose standardization and harmonized approach for configuration.

• Manage major and minor releases, including a risk-based approach for validation and implementation.

Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and organizational growth.

• Bachelor's degree in computer science or technology with at least 5+ years' direct experience working with Veeva Vault Technologies implementation and establishing enduring Governance to drive strategic Product Roadmap Deliveries.
• Experience with the Veeva Vault Development Platform, including QDocs, Training, RIM, QMS, CTMS and cross-domain integrations.
• Experience and knowledge of quality and regulatory business processes.
• Direct hands-on experience implementing GxP computerized systems and maintaining validated state.
• Strong process improvement skills and orientation.
• Must have proven business and technology skills in successfully providing a customer-oriented technology solutions environment.
• Proven strong communication skills in interacting with users and technical communities.
• Ability to communicate ideas in both technical and user-friendly language.
• Collaborative working approach.

Computer Skills:

• Certified Veeva System Administrator - Required.
• Veeva Vault Owner/System Administration Experience (Quality QMS (Quality Management System), Quality QualityDocs and Training, RIMS/Submissions, Clinical, Safety, Station Manager, Vault Mobile, etc.)
• Experience with Other Regulated Applications would be an asset
• Database and computer networking knowledge
• Experience working on SaaS (Software as a Service) systems

Working conditions

This position operates primarily in an office setting and may include 10% of travel. Mandatory onsite presence is required.

Physical Requirements

This is a largely sedentary role.

Direct Reports

None

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.